NCT03340051

Brief Summary

Nearly 18% of United States adults meet criteria for alcohol dependence sometime in their lifetime, with only 24% of those individuals ever receiving any treatment for their disorder (Hasin et al., 2007). The pervasiveness of alcohol dependence indicates a need for continued development of high-impact treatments that are both effective and easily disseminated to a broad population. Recent evidence indicates that Episodic Future Thinking (EFT), the ability to self-project and pre-experience a future event, can help individuals to make changes to habitual behaviors, such as alcohol drinking (Snider et al., 2016). In this study, the investigators will evaluate the efficacy of EFT to help individuals reduce alcohol consumption. The investigators anticipate that EFT will result in a reduction in alcohol consumption over a 2-week experimental period when compared to the control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2019

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

November 3, 2017

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in average daily alcohol consumption

    Change in average daily alcohol consumption collected using self reports

    Self report of daily alcohol use will be collected every morning for 7 days after the first session (baseline measure) and for 14 days after the second session and the averages of the 7- and 14-day periods will be compared (pre-post intervention).

Secondary Outcomes (3)

  • Change in delay discounting rate

    At the first session (baseline measures), third session (after 3 weeks/post-intervention), and the 1 month follow up assessments. The average discounting rates within each group will be compared pre-post intervention

  • Change in intensity of alcohol demand

    At the first session (baseline measures), third (after 3 weeks/post-intervention), and the 1 month follow up assessments. The average scores within each group will be compared pre-post intervention

  • Change in elasticity of alcohol demand

    At the first session (baseline measures), third (after 3 weeks/post-intervention), and the 1 month follow up assessments. The average scores within each group will be compared pre-post intervention

Study Arms (2)

EFT group

ACTIVE COMPARATOR

Episodic Future Thinking (EFT) is the intervention in this arm. EFT participants will generate positive future events they are looking forward to and that could happen at different future time points (e.g., in 2 weeks, 1 month, 6 months, 1 year). Participants will be instructed to use and think about their episodic cues as they make decisions.

Behavioral: Episodic Future Thinking (EFT)

ERT group

PLACEBO COMPARATOR

Episodic Recent Thinking (ERT) is the intervention in this arm. ERT participants will list positive recent events (events that have already happened) that they enjoyed that occurred at different past time points (e.g., 12 hours ago, 24 hours ago, a week ago). Participants will be instructed to use and think about their episodic cues as they make decisions.

Behavioral: Episodic Recent Thinking (ERT)

Interventions

EFT participants will generate positive future events they are looking forward to and that could happen at different future time points (e.g., in 2 weeks, 1 month, 6 months, 1 year). Participants will be instructed to use and think about their episodic cues as they make decisions.

EFT group

ERT participants will list positive recent events (events that have already happened) that they enjoyed that occurred at different past time points (e.g., 12 hours ago, 24 hours ago, a week ago). Participants will be instructed to use and think about their episodic cues as they make decisions.

ERT group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • provide written informed consent
  • be 18-65 years old
  • meet DSM-V criteria for moderate or severe alcohol use disorder
  • express a desire to quit or cut down on their drinking.

You may not qualify if:

  • Individuals who are:
  • pregnant or lactating
  • meet DSM-V criteria for any other moderate or severe substance use disorders (excluding caffeine, nicotine, and marijuana),
  • score 23 or greater on the Alcohol Withdrawal Symptom Checklist (a score indicating that medication would be likely required to manage alcohol detoxification)
  • use prescribed or over-the-counter medicines containing alcohol
  • participated in any previous studies that included EFT at the Addiction Recovery Research Center in the last three months
  • have immediate plans to move out of the area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

Related Publications (1)

  • Athamneh LN, Brown J, Stein JS, Gatchalian KM, LaConte SM, Bickel WK. Future thinking to decrease real-world drinking in alcohol use disorder: Repairing reinforcer pathology in a randomized proof-of-concept trial. Exp Clin Psychopharmacol. 2022 Jun;30(3):326-337. doi: 10.1037/pha0000460. Epub 2021 Apr 22.

MeSH Terms

Conditions

AlcoholismAlcohol-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Warren K Bickel, PhD

    Virginia Tech Carilion School of Medicine and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 13, 2017

Study Start

September 21, 2017

Primary Completion

September 17, 2019

Study Completion

October 3, 2019

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations